A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This research project will investigate the effects of pramlintide (Symlin) given by continuous subcutaneous (under the skin) infusion throughout the day and night, along with meal doses similar to those injected during conventional pramlintide (Symlin) treatment, delivered using a second insulin pump, in subjects with inadequately controlled type I diabetes mellitus who are already using insulin pump therapy. Study participants will wear two pumps for a four month period, taking insulin in their usual manner and pramlintide (Symlin) in a similar basal/bolus fashion. Continuous glucose monitors will be worn on three occasions during the study to assess blood glucose responses to continuous pramlintide (Symlin) treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Diabetes & Endocrine Consultants
• Collaborator: Amylin Pharmaceuticals, LLC.
• Treatments: Insulin; Islet Amyloid Polypeptide; Pramlintide

Criteria

Inclusion Criteria:

1. Type 1 diabetes of at least one year duration;

2. Treated with CSII therapy for at least 6 months;

3. Age 18 to 70 years, inclusive;

4. A1C >7.0 and ≤10% as screening;

5. BMI ≤35 kg/m2;

6. Stable insulin dose (±10%) for at least 3 months prior to screening;

7. If female, has a negative urine pregnancy test at screening;

8. If female and of childbearing potential, practicing and willing to continue to using appropriate contraception to ensure that pregnancy does not occur during the study;

9. Able to understand and sign the required study documents and comply with the protocol requirements

Exclusion Criteria:

1. Is poorly compliant with the currently prescribed insulin regimen, as determined by the investigator;

2. Has any significant medical condition, laboratory findings, or medical history that may affect successful completion of the study and/or personal well-being;

3. If female and if of childbearing potential, is pregnant, lactating, or planning to become pregnant;

4. Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months;

5. Has a history of hypoglycemia unawareness;

6. Has a confirmed diagnosis of gastroparesis;

7. Requires the use of drugs that stimulate gastrointestinal motility;

8. Is receiving medications known to interfere with glycemic control (i.e. glucocorticoids);

9. Has been treated with any oral antidiabetic agent or exenatide within 3 months of screening visit;

10. Has been treated with pramlintide within 3 months of screening visit;

11. Has received an investigational drug within 3 month of screening visit;

12. Is currently participating in a clinical trial